Conventional Test Method:

Acute Eye Irritation/Corrosion (Draize rabbit eye irritation test) (OECD TG 405)

Alternative Test Method:

Name & Description:

Fluorescein Leakage Test

a cytotoxicity and cell-function based in vitro assay that is performed on a confluent monolayer of  CB997 tubular epithelial cells that are grown on semi-permeable inserts and model the non-proliferating state of the in vivo corneal epithelium.

Validation Status:

EU: Endorsed as valid by ESAC (2009).

Regulatory Status:

OECD: TG 460 (2012)

Effect or Potential Effect on Animal Use:

Reduction 
(Substances identified as irritants by test will not progress to animal testing)

References:

• ECVAM (2009) Statement on the scientific validity of cytotoxicity/cell-function based in vitro assays for eye irritation testing.
• ECVAM DB-ALM (2010) Fluorescein Leakage (FL) Test INVITTOX no 71.
• OECD (2011) Draft TG on a Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants, OECD Guidelines for the Testing of Chemicals, Section 4 Health Effects.
• OECD (2012) Test No. 460: Fluorescein leakage test method for identifying ocular corrosive and severe irritants, OECD Guidelines for the Testing of Chemicals, Section 4 Health Effects.

Information Last Reviewed:

May 2012